Tobacco is a primary risk factor for cancers of the head and neck. There is evidence that patients with head and neck cancer who continue to smoke following diagnosis are at increased risk for developing second primary tumors, recurrence, reduced response to treatment, and reduced survival. Although a high percentage of head and neck patients abstain from smoking following diagnosis, data from the M.D. Anderson Cancer Center (MDACC) Tobacco Treatment Program (TTP) and other studies suggest that 28 percent to 46 percent of patients continue to smoke. Data from the MDACC TTP and other studies also indicate that a high proportion of head and neck cancer patients who continue to smoke following diagnosis present with a variety of factors that may complicate their efforts to quit, including high levels of nicotine dependence, high levels of emotional distress related to their cancer, and comorbid depressive, anxiety and alcohol use disorders. This suggests that this subpopulation of patients may need an intensive treatment that more effectively addresses these barriers to cessation. The goals of this study are to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis that is based on Acceptance and Commitment Therapy (ACT), an existing treatment that has been found to be efficacious in the treatment of smoking, substance dependence disorders, and distress in cancer patients; to conduct a small preliminary randomized trial to examine its effects on both short and long-term point prevalence and prolonged abstinence, and quality of life relative to an existing motivational and behavioral smoking cessation treatment (MBC); and, to evaluate whether ACT's hypothesized treatment mechanisms mediate ACT's effect on abstinence and whether these mediators differ from variables that mediate MBC's effect on abstinence. The project will take place in two phases. In the first phase (Stage Ia), we will modify content from existing Acceptance and Commitment Therapy treatment protocols for use as a smoking cessation intervention for head and neck patients who continue to smoke following diagnosis. During this phase, 20 head and neck patients recruited through the MDACC TTP, will complete the protocol, which will be modified and refined based upon feedback from patients, ACT treatment experts, and study therapists. In the second phase (Stage Ib), 67 head and neck patients who continue to smoke following diagnosis will be recruited through the MDACC TTP and randomly assigned to either ACT or the TTP standard MBC treatment. Varenicline will be included as part of treatment in both conditions. Based on the outcome of this preliminary trial, the ACT treatment protocol will be further refined and readied for larger-scale clinical trials. PUBLIC HEALTH RELEVANCE: The goal of this study is to develop an intensive smoking cessation intervention for head and neck patients who continue to smoke following diagnosis, and to provide preliminary information about its effectiveness. Acceptance and Commitment Therapy (ACT) is an existing treatment that has been found to be effective in the treatment of substance use disorders and distress in cancer patients. We will modify and develop this treatment as a smoking cessation intervention and then run a small trial to see whether ACT is more effective in helping head and neck cancer patients quit and in improving their quality of life, compared to the currently available counseling treatment. If ACT is found to be more effective, it could be further tested in larger studies.